Firmonertinib Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials from Phase II to Phase IV are evaluating firmonertinib in locally advanced, metastatic, and EGFR-mutant non-small cell lung cancer featuring uncommon, P-loop, or alpha C-helix alterations, as well as CNS and leptomeningeal metastases. Sponsored by pharmaceutical corporations, including Allist Pharmaceuticals and ArriVent BioPharma, alongside academic medical centers, these studies range in status from active recruitment to not yet recruiting. Key ongoing research includes several clinical trials assessing firmonertinib as adjuvant therapy and against comparative treatments in advanced disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07298148	NOT_YET_RECRUITING	NSCLC Stage IV; EGFR Positive Non-small Cell Lung Cancer; EGFR-TKI Sensitizing Mutation	Peking University Cancer Hospital & Institute	2026-01-01	PHASE2
NCT07314216	RECRUITING	NSCLC (Non-small Cell Lung Carcinoma); Stage III; EGFR Uncommon Mutations	Hunan Cancer Hospital	2026-06-22	PHASE2
NCT07182708	NOT_YET_RECRUITING	NSCLC (Non-small Cell Lung Cancer); EGFR Activating Mutation; Resectable Lung Non-Small Cell Carcinoma	Peking University Cancer Hospital & Institute	2025-10-01	PHASE2
NCT07661173	NOT_YET_RECRUITING	Non Small Cell Lung Cancer	Anhui Provincial Cancer Hospital	2026-06-06	PHASE2
NCT07185997	RECRUITING	Non-Small-Cell Lung Cancer; Metastatic Non-Small-Cell Lung Cancer; Advanced Non-Small-Cell Lung Cancer; EGFR P-Loop and Alpha C-Helix Compressing; EGFR PACC; EGFR Uncommon Mutations	ArriVent BioPharma, Inc.	2025-12-17	PHASE3
NCT07010419	RECRUITING	NSCLC; Adjuvant Treatment	Allist Pharmaceuticals, Inc.	2025-05-28	PHASE3
NCT07622706	NOT_YET_RECRUITING	NSCLC; EGFR Positive Non-small Cell Lung Cancer; Neoadjuvant Therapy	Peking University Cancer Hospital & Institute	2026-05-30	PHASE2
NCT06668103	RECRUITING	Non-Small Cell Lung Cancer With EGFR Mutation	Abbisko Therapeutics Co, Ltd	2024-11-25	PHASE2
NCT06956001	RECRUITING	EGFR; NSCLC (Advanced Non-small Cell Lung Cancer)	Allist Pharmaceuticals, Inc.	2024-11-19	PHASE3
NCT07092202	RECRUITING	Leptomeningeal Metastasis; NSCLC; Intrathecal Chemotherapy; Tyrosine Kinase Inhibitor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	2025-04-15	PHASE4
NCT06971406	NOT_YET_RECRUITING	Non Small Cell Lung Cancer; EGFR Mutation; Leptomeningeal Metastases; Targeted Therapy	Qiming Wang	2025-05-15	PHASE2
NCT06890182	NOT_YET_RECRUITING	Non-small Cell Lung Cancer	Tianjin Medical University Cancer Institute and Hospital	2025-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-21)

Check the Firmonertinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Firmonertinib selectively binds to mutant epidermal growth factor receptor tyrosine kinases—including exon 20 insertion, T790M, and uncommon variants—inhibiting receptor autophosphorylation and downstream oncogenic signal transduction to arrest cell proliferation and induce apoptosis in tumor cells. This targeted brain-penetrant kinase inhibition underpins its therapeutic application in patients with advanced EGFR-mutant non-small cell lung cancer and secondary central nervous system or leptomeningeal metastases.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).